BACKGROUND: The safety and efficacy of Seprafilm (Genzyme Corporation, Cambridge, Mass) in adult surgery patients have been established. The aim of this study was to evaluate the safety and efficacy of Seprafilm in pediatric surgical patients. METHODS:One hundred twenty-two pediatric abdominal surgery patients were enrolled. Sixty-seven patients received Seprafilm application. Of these patients, 18 again received Seprafilm at abdominal closure during a second surgery, and of the 18, 4 received Seprafilm at closure after a third surgery. Of the 55 control patients who did not receive Seprafilm, 14 had a second surgery, and of these 14 patients, 4 had a third surgery. Adverse events, operation time, and blood loss were compared with assessed Seprafilm safety. Seprafilm efficacy evaluations included incidence and severity of adhesions in those patients who required relaparotomy. RESULTS: The incidence (Seprafilm, 40.9%; control, 82.4%) and severity (Seprafilm: 59.1%, grade 0; control: 17.6%, grade 0) of adhesions under the abdominal incision site were significantly reduced in the Seprafilm group (P = .007 and P = .0009, respectively). In addition, mean relaparotomy operation time was significantly shorter for Seprafilm patients (P = .004). At relaparotomy, blood loss/body weight ratio for Seprafilm patients compared with control patients showed a trend toward but did not reach significance (P = .09). CONCLUSIONS: Decreased incidence and severity of postsurgical adhesions with Seprafilm in pediatric patients may lead to reduction of the risks associated with subsequent operation.
RCT Entities:
BACKGROUND: The safety and efficacy of Seprafilm (Genzyme Corporation, Cambridge, Mass) in adult surgery patients have been established. The aim of this study was to evaluate the safety and efficacy of Seprafilm in pediatric surgical patients. METHODS: One hundred twenty-two pediatric abdominal surgery patients were enrolled. Sixty-seven patients received Seprafilm application. Of these patients, 18 again received Seprafilm at abdominal closure during a second surgery, and of the 18, 4 received Seprafilm at closure after a third surgery. Of the 55 control patients who did not receive Seprafilm, 14 had a second surgery, and of these 14 patients, 4 had a third surgery. Adverse events, operation time, and blood loss were compared with assessed Seprafilm safety. Seprafilm efficacy evaluations included incidence and severity of adhesions in those patients who required relaparotomy. RESULTS: The incidence (Seprafilm, 40.9%; control, 82.4%) and severity (Seprafilm: 59.1%, grade 0; control: 17.6%, grade 0) of adhesions under the abdominal incision site were significantly reduced in the Seprafilm group (P = .007 and P = .0009, respectively). In addition, mean relaparotomy operation time was significantly shorter for Seprafilmpatients (P = .004). At relaparotomy, blood loss/body weight ratio for Seprafilmpatients compared with control patients showed a trend toward but did not reach significance (P = .09). CONCLUSIONS: Decreased incidence and severity of postsurgical adhesions with Seprafilm in pediatric patients may lead to reduction of the risks associated with subsequent operation.